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Quality Control Senior Associate

The Steely Group

Holly Springs, NC

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Change Control, Cross-Functional, Detail Oriented, Documentation Review, GMP (Good Manufacturing Practices), Laboratory Operations, Leadership, Metrics, Onboarding, Quality Assurance, Quality Assurance Methodology, Quality Control, Secondary School, Standard Operating Procedures (SOP), Startup, Support Documentation, Team Lead/Manager, Trend Analysis, Validation Documentation, Writing Skills
LOCATION
Holly Springs, NC
POSTED
30+ days ago
This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion.

Experience with Veeva Quality Systems is highly desirable.

This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

Responsibilities/Duties
  • Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
  • Individual will lead investigation teams and help to collect and report metrics for the systems team
  • Individual may assist with review of validation documents to support equipment and computerized system onboarding.
  • Individual may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
  • Support the startup of a GMP QC laboratory.
  • Support routine activities over the weekends and public holidays as required.

Qualifications    
  • High school/GED + 2 years work experience OR Associates and 6 months work experience OR Bachelors
  • At least 3 years of industry experience within a GMP-regulated biotech or pharmaceutical environment
  • Demonstrated strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.

About the Company

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The Steely Group